5.2 Requirement

5.3. Preparation of Sterile RODAC plate

5.3.1 Preparation of Soybean casein digest agar containing with 0.5% Soya lecithin & 4 % Polysorbate – 20 as per the following manner.5.3.2 As per the instruction, weigh the specified quantity of media powder in a beaker, whose capacity is double than the final volume of media to be prepared. 5.3.3 Add also 0.5% of Soya lecithin & 4 % Polysorbate – 20 as per medium quantity.5.3.4 Add appropriate quantity of distilled water and mix it properly.5.3.5 Check the pH of the medium and set the pH using 0.1 N HCl / 0.1 N NaOH if required.5.3.6 Heat and dissolved the medium constituents with constant stirring to avoid charring.5.3.7 In the molten state, distribute the specific volume of the media into the appropriate glass container.5.3.8 Seal the mouth of the glass container using cotton plug only.5.3.9 Affix the label with Name of media on each container.5.3.10 Cover the cotton plug with wrapping paper.5.3.11 Unless specified, sterilize the media at 121°C for 20 min as per SOP.5.3.12 After completion of the sterilization cycle, pour sterile Soybean casein digest agar + 0.5 % Soya –Lecithin & 4 % Polysorbate – 20 in each pre – sterilized and dry plate under Laminar air flow bench till convex surface achieved and allow it to solidify.5.3.13 After solidification of medium, incubate the RODAC plate at 30°C – 35°C for 48 Hrs.5.3.14 After incubation observe the plates for contamination and contaminated plates must be discarded.5.3.15 Tag the label as Date of preparation of Medium , Medium Lot. No, Date of use Before on sterile RODAC plate and store in refrigerator.

5.4. Procedure for Surface testing by RODAC plate5.4.1 Mop the outer surface of RODAC plates with 70% Isopropyl alcohol and transfer them to the Parenteral Department.5.4.2 Open the RODAC plate and contact them on sampling site ( surface) as per schedule.5.4.3 After contact close the RODAC plate and spray the disinfectant solution on the sampling surface and mop it with sterile cloth/mopper.5.4.4 After sampling, incubate the plates at 30°C – 35°C for 72 Hrs, and then record the results in terms of CFU / plates in Annexure – I , II, III, IV.
5.5 Procedure For Surface testing by Sterile Swab sticks5.5.1 Swab should only be used when it is not possible to use RODAC for the swab test. A cotton stick ( swab ) should be preferred. The swab should be moistened in sterile saline or sterile water & rubbed on the sampling site and then rubbed in a SCD agar plate. All operations made in the sampling area.5.5.2 After sampling incubate the plates at 30°C – 35°C for 72 Hrs and then record the results in terms of CFU / plate in Annexure – I.Limit : Results CFU per sample.

Class

Location

Alert Level

Action Level

100

* Critical sites ( Filling line , Needle , Cap Track )

* 1

* > 1

Other sites

1 – 3

> 3

10,000

Above Floor level

3 – 5

> 5

At floor level

7 – 10

> 10

100,000

Pre & Wash

Above Floor level

15 - 25

> 25

At floor level

25 - 50

> 50

100,000

Other area

Above Floor level

25 – 50

> 50

At floor level

50 – 100

> 100

Acceptance criteria: Bacterial Colony should be within Limit or Fungi should be Absent.5.6 Following sites are to be covered within week.